Intelligent Integrity Tester

Intelligent Integrity Tester
Product Description

Features:- High-level hardware to ensure data stability and accuracy
- Special structure design effectively prevents water from sucking back and self-check function
- Powerful windows system supports real-time display of test curves
- 128 GB hard disk drive capacity and 16 GB RAMBackup date can be exported on user demand
- Support multi-level user access settings to ensure data is integrated and safe
- Automated network function (optional)

Masterfilter GmbH

  • Country/Region:
    Germany
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1 - 24
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Biopharmaceutical
Specifications
  • Details
    The Certitest® 20 Plus ensures an accurate filter integrity testing with a reduction in test duration and complies entirely with the FDA 21 CFR Part 11 guidance on electronic records. Features as automation and network integration will save time and effort.
    Designed to be used in cleanroom environment, the Certitest® 20 Plus has been developed and validated in accordance with the current GAMP guidelines. The Integrity tester includes the requisite controls and other features for operation in a 21 CFR Part 11 compliant environment. Data integrity controls, electronic records and signatures are available to support quality risk analysis.

  • Model
    Certitest20 Plus

Masterfilter GmbH

  • Country/Region:
    Germany
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1 - 24
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Biopharmaceutical

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Masterfilter GmbH resources (1)

  • News NEW Blown Film for Single-Use Bags

    The innovative Topene™ RB blown film designed for biological processes is composed of ULDPE, EVA, EVOH and LDPE. The ULDPE layer with low extractability, low precipitation, good chemical compatibility and biological safety is used as the liquid contact layer. The EVA layer has good resistance to flexural cracking and the EVOH layer minimizes gas diffusion of the film. The outer LDPE layer provides strong puncture resistance, strength and excellent thermal stability.

    The Topene™ RB film has an ultra-clean inner surface, good environmental stress resistance, tear resistance, rubbing resistance, tensile resistance, chemical stability and biological safety.

    Features:
    - Highest quality standards- Short delivery times
    - Experienced technical support
    - Optimized production cost